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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Novartis |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00081874 |
The goal of this clinical research study is to find the highest safe dose of RAD001 that can be given as a treatment for leukemia, mantle cell lymphoma, or myelofibrosis. Another goal is to learn how effective the dose that is found is as a treatment. RAD001 is a new drug that was designed to block proteins that are important in the development and growth of cancer.
Condition | Intervention | Phase |
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Leukemia Mantle Cell Lymphoma Myelofibrosis |
Drug: RAD001 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Study of RAD001 in Patients With Relapsed or Refractory Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Chronic Myeloid Leukemia in Blastic-Phase, Agnogenic Myeloid Metaplasia, Chronic Lymphocytic Leukemia, T-Cell Leukemia, or Mantle Cell Lymphoma |
Estimated Enrollment: | 125 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | October 2004 |
RAD001 (Everolimus), an ester of the macrocytic immunosuppressive agent sirolimus (rapamycin, Rapamune™), is an orally administered cell cycle inhibitor with antitumor properties. RAD001 is approved in Europe as an immunosuppressive agent in patients who have received a prior solid organ transplant. RAD001 specifically inhibits the mammalian target of rapamycin (mTOR), a Ser/Thr kinase involved in the initiation of mRNA translation. RAD001 inhibits the growth of a wide range of histologically diverse tumor cells. RAD001 is being developed as a cytostatic agent to delay the time to tumor recurrence/progression or to increase survival in patients with various malignancies. Key features of this compound include its good tolerability, unique mechanism of action, ability to arrest cells in the G1 phase, and ability to induce apoptosis. As mTOR-related messengers, particularly PI3K, AKT, p70S6K kinase and 4E-BP1, are known to be both constitutively activated in the hematologic malignancies and to mitigate against the activity of current anti-leukemia therapy, RAD001 is an important agent to study in these disorders.
Objectives:
Primary: To establish the safety and activity of RAD001 in patients with advanced, relapsed or refractory acute myeloid leukemia, myelodysplastic syndrome, acute lymphocytic leukemia, chronic myeloid leukemia in blastic-phase, agnogenic myeloid metaplasia (myelofibrosis), chronic lymphocytic leukemia, T-cell leukemia, and mantle cell lymphoma.
Secondary:
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 2003-0948 |
Study First Received: | April 23, 2004 |
Last Updated: | September 29, 2006 |
ClinicalTrials.gov Identifier: | NCT00081874 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Leukemia, Lymphoid Immunologic Factors Lymphoma, Mantle-Cell Mantle Cell Lymphoma Leukemia, Myeloid, Acute Leukemia Acute Myelocytic Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Metaplasia Leukemia, B-cell, Chronic Lymphoma Acute Lymphoblastic Leukemia Everolimus Myelofibrosis Precursor Cell Lymphoblastic Leukemia-Lymphoma |
Immunoproliferative Disorders Hematologic Diseases Myeloproliferative Disorders Leukemia, Myeloid Immunosuppressive Agents Myeloid Metaplasia Lymphatic Diseases Chronic Lymphocytic Leukemia Leukemia, T-Cell Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chronic Myelogenous Leukemia Bone Marrow Diseases Leukemia, B-Cell Lymphoproliferative Disorders Lymphoma, Non-Hodgkin |
Leukemia, Lymphoid Immunologic Factors Lymphoma, Mantle-Cell Physiological Effects of Drugs Leukemia Pathologic Processes Leukemia, Lymphocytic, Chronic, B-Cell Metaplasia Lymphoma Everolimus Myelofibrosis Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases |
Hematologic Diseases Myeloproliferative Disorders Leukemia, Myeloid Immunosuppressive Agents Pharmacologic Actions Myeloid Metaplasia Lymphatic Diseases Neoplasms Leukemia, T-Cell Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases Leukemia, B-Cell Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Splenic Diseases |